Z-1330-2013Class III

Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an...

Name: Z-1330-2013 Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an...
Creator: Bio-rad Laboratories, Inc.
Published: 2013-04-15
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2013-04-15 / Terminated / root cause: manufacturing process

FDA source

Bio-rad Laboratories, Inc. began a recall of Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of... on 2013-04-15. FDA classified it as Class III and gives the reason as "The Liquichek" ToRCH Plus IgM Control - Positive, contains detectable levels of HCV RNA which originated from the non-specific human IgM component used in the mouse monoclonal antibody conjugation process for this...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1330-2013
Classification: Class III
Status: Terminated
Initiated: 2013-04-15
Posted: 2013-05-16
Terminated: 2013-08-01
Recalling firm: Bio-Rad Laboratories Inc.
Product: Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays. Analytes claimed with this lot of Liquichek ToRCH Plus IgM Control: Cytomegalovirus (CMV) IgM Herpes Simplex Virus Type 1/2 (HSV-1/2) IgM Rubella Virus IgM Toxoplasma gondii IgM
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: The Liquichek" ToRCH Plus IgM Control - Positive, contains detectable levels of HCV RNA which originated from the non-specific human IgM component used in the mouse monoclonal antibody conjugation process for this product.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Bio-rad Laboratories initiated this recall on April 18, 2013, via telephone call and certified mailing to customers. The notification letter titled "Important Product Information Notice of Correction" was accompanied by a "Field Correction Notification Acknowledgement" form that notified customers of the product for recall (description and codes), issue (This product contains detectable levels of HCV RNA which originated from the non-specific human IgM component used in the mouse monoclonal antibody conjugation process for this product), Customers were instructed to immediately discontinue use this lot of Liquichek ToRCH Plus IgM Control. Discard all remaining inventory of this lot of Liquichek ToRCH Plus IgM Control that you have at your location in accordance with the requirements of your local waste management authorities. Handle this product with the same precautions used with patient specimens. In accordance with good laboratory practice, all human source material should be considered potentially infectious. Have the appropriate laboratory personnel complete the acknowledgment form and email or fax it to us. It is very important to us to know that you have received the information provided in this Notice. Contact information (1-800-2-BIORAD)
Quantity in commerce: 211 boxes and 5 MiniPaks
Distribution: Worldwide Distribution - Distributed in San Juan Puerto Rico and the states of NM, NY, MN, OR and WI., and the countries of Australia, Brazil, France, Italy, Korea, and New Zealand.
Product codes and lots: Lot Number 18972, Catalog Number 229 and 229PX.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1330-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1330-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-16

Product code JJY

K040822Class ILiquichek Torch Plus Igm ControlBio-Rad Laboratories, Inc. / cleared 2004-05-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)